A Randomised Double-Blind, Double Dummy Trial to Compare the Efficacy and Safety of Arimidex with Tamoxifen as First line Therapy for Advanced Breast Cancer in Post-Menopausal Women
| ISRCTN | ISRCTN74551156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74551156 |
| Secondary identifying numbers | ZEN1033IL/27 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 28/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised Double-Blind Double Dummy Trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | A Randomised Double-Blind, Double Dummy Trial to Compare the Efficacy and Safety of Arimidex with Tamoxifen as First line Therapy for Advanced Breast Cancer in Post-Menopausal Women |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | 1. Group A: Arimidex (anastrozole) 1 mg plus tamoxifen placebo daily 2. Group B: Tamoxifen 20 mg plus Arimidex placebo daily |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Arimidex with Tamoxifen |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1996 |
| Completion date | 01/07/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Patients with locally advanced or metastatic breast cancer who are candidates to receive hormonal therapy as first line therapy for advanced disease (patients may have received adjuvant chemotherapy or hormonal therapy but patients who have received tamoxifen as adjuvant therapy must have an interval of at least 12 months since stopping tamoxifen and entry into this trial) 2. Post-menopausal defined as: 2.1 Aged >50 years or who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone (FSH) levels within the post-menopausal range 2.2 Women aged <50 years who have FSH levels within the post-menopausal range 3. Hormone receptor (oestrogen receptor and or progesterone receptor) positive or unknown 4. Measurable or evaluable disease 5. No previous systemic therapy for advanced breast cancer 6. No drug-maintained menopausal status 7. No evidence of life threatening visceral disease 8. Life expectancy of >3 months 9. No treatment with a non-approved or experimental drug within the preceding 3 months before randomisation 10. No prior history of other malignancy other than breast cancer, except basal cell or squamous cell carcinoma of the skin or cancer of the cervix which has been satisfactorily controlled 11. No contraindications to protocol treatments |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1996 |
| Date of final enrolment | 01/07/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
AstraZeneca Clinical Research Group (UK)
Industry
Industry
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
| Website | http://www.astrazeneca.co.uk |
|---|---|
"ROR" |
https://ror.org/04r9x1a08 |
Funders
Funder type
Industry
AstraZeneca Pharmaceuticals (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
28/11/2019: No publications found. All search options exhausted.
